Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall RoyalSilk Non-Reinforced Surgical Gowns XX-large Potential for open packaging seals compromising the sterility of the surgical gowns Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long Potential for open packaging seals compromising the sterility of the surgical gowns Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion;… Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use Instructions for use were updated to include additional information to facilitate the selection and use of the collar device. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Boston Scientific ROTAPRO, Rotational Atherectomy System Console Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal… Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida, Nevada, New York, Ohio, Pennsylvania and Washington named
- Medical device recall Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current… Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay Class IIFDA’s classDec 22, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereOhio and Utah
- Medical device recall BioGlue Surgical Adhesive Product is not approved for use in the EU and should not have been distributed in the EU. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Box Label: activ5 TINY GYM IN YOUR POCKET activbody Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement Report44 statesnamed in where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall activforce 2 package labeling Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement Report44 statesnamed in where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Flexor Check-Flo Introducer Ansel Modification Flexor Check-Flo Introducer Ansel Modification mislabeled. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Georgia, Kansas, Michigan, Minnesota, Missouri, North Carolina, New York, Oklahoma and Texas
- Medical device recall Flexor Check-Flo Introducer Ansel Modification Flexor Check-Flo Introducer Ansel Modification mislabeled. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Georgia, Kansas, Michigan, Minnesota, Missouri, North Carolina, New York, Oklahoma and Texas
- Medical device recall Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system Base plate may detach from the main body of the treatment applicator. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72 The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: “This patient has a… Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNorthern Mariana Islandsthe one state its words name PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNorthern Mariana Islands
- Medical device recall Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: “This patient has a… Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNorthern Mariana Islandsthe one state its words name PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNorthern Mariana Islands
- Medical device recall Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide… Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth… Class IIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 15, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device. Class IIFDA’s classDec 15, 2021in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedDec 15, 2021ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for… Due to product label/labeling being altered from it’s approved state. Class IIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedDec 15, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient. Class IIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedDec 15, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Puritan Bennett 980 Series Ventilator, 980A1ENNISB Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980A3ENNISB Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980S1ENDICU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980S3ENDICU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980U1ENASAA Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980U1ESDIUC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980U3ESDIUU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator,980X1ENAIQC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980X1ENDIPC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980X1ENDIUU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980X1ENNISB Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980X1JADIJJ Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980X1PLDIPC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980X2ESDIEC Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980X3ENDIUU Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Series Ventilator, 980X3JADIJJ Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments. Class IIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedDec 15, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the… Class IIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the… Class IIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the… Class IIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with… Excessive ultraviolet-C radiation Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abbott HeartMate Touch Communication System If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth… Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall NuStat 8” x12” Trauma Pad XR Hemafiber, 5-pack Endotoxin levels exceeded allowable limits. Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportMissourithe one state its words name PublishedDec 8, 2021ClassClass IIStatusOngoingWhereMissouri
- Medical device recall Total Thyroxine (T4) ELISA Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNew York
- Medical device recall SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed… Class IIIFDA’s classDec 8, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 8, 2021ClassClass IIIStatusOngoingWhereDistrict of Columbia, Massachusetts, South Carolina and Virginia
- Medical device recall BioFire Blood Culture Identification 2 (BCID2) Panel Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 28MM -4 LFIT V40 HEAD XXX Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 8, 2021ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall 28MM -4 LFIT V40 HEAD There is a potential for the outer white Tyvek lid to debond from the sealed package. Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 8, 2021ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS The package contents and package labeling do not match. Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Michigan and Pennsylvania named
- Medical device recall INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS The package contents and package labeling do not match. Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Michigan and Pennsylvania named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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